FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
122857–122880 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 14, 1991
SUNGLASSES, NON-PRESCRIPTION (ITALO CREMONA)
K910126 · HQY
The Limited Stores, Inc.
Ophthalmic · 66d
Cleared Mar 14, 1991
SUNGLASSES, NON-PRESCRIPTION (POLINELLI)
K910127 · HQY
The Limited Stores, Inc.
Ophthalmic · 66d
Cleared Mar 14, 1991
EMIT CONVENIENCE PACK FOR THE COBAS MIRA PRIMIDONE
K910527 · DJD
Syva Co.
Toxicology · 35d
Cleared Mar 13, 1991
RENALYZER PRX 90
K903034 · CGL
Swedish Trade Council USA
Chemistry · 245d
Cleared Mar 13, 1991
ON-SITE ALCOHOL
K903223 · DOJ
Toxi-Lab, Inc.
Toxicology · 233d
Cleared Mar 13, 1991
SURGITEK(R) LUBRI-FLEX(TM) URETERAL STENT
K905289 · FAD
Medical Engineering Corp.
Gastroenterology & Urology · 107d
Cleared Mar 13, 1991
MANHANDLER
K905381 · FPP
Lifeport, Inc.
General Hospital · 104d
Cleared Mar 13, 1991
MICROLINE SCREEN FOR OPIATES
K905491 · DJG
Drug Screening Systems, Inc.
Toxicology · 96d
Cleared Mar 13, 1991
PEDICRAFT INFANT REFLUX WEDGE
K905629 · FRP
Pedicraft, Inc.
General Hospital · 89d
Cleared Mar 13, 1991
INFANT REFLUX SLING
K905630 · FRP
Pedicraft, Inc.
General Hospital · 89d
Cleared Mar 13, 1991
VITAL-PORT(TM) M.R.I. VASCULAR ACCESS SYSTEM
K910005 · LJT
Med Institute, Inc.
General Hospital · 70d
Cleared Mar 13, 1991
DENTRONIX MODEL 2000
K910202 · KMH
Dentronix, Inc.
General Hospital · 62d
Cleared Mar 13, 1991
MTP TRANSPORT INFUSION PUMP, MODEL NO. MTPLEA
K910335 · FRN
Medical Technical Products
General Hospital · 47d
Cleared Mar 13, 1991
3M MODEL 8240 ITE HEARING AID
K910690 · ESD
3M Company
Ear, Nose, Throat · 22d
Cleared Mar 12, 1991
STERILE SURGEON'S GLOVES
K902449 · KGO
Unigloves , Ltd.
General Hospital · 284d
Cleared Mar 12, 1991
ADVANCED ISCHEMICA RECORDERS MODEL 2000 CASSETTE
K902766 · DSH
Advanced Ischemia Recorders, Inc.
Cardiovascular · 264d
Cleared Mar 12, 1991
RETAINER, SCREW EXPANSION ORTHODONTIC
K903498 · EJF
Masel Industries, Inc.
Dental · 221d
Cleared Mar 12, 1991
BACT/ALERT (TM)
K903505 · MDB
Organon Teknika Corp.
Microbiology · 221d
Cleared Mar 12, 1991
CLOSTRIDIUM DIFFICILE TOXIN A ENZYME IMMUNOASSAY
K904329 · MCB
Baxter Healthcare Corp
Microbiology · 173d
Cleared Mar 12, 1991
SPIROLOOP, MODIFICATION
K904633 · CCJ
Pneumedics, Inc.
Anesthesiology · 168d
Cleared Mar 12, 1991
SYVA MICROTRAK CHLAMLYDIA EIA, MODIFICATION
K905179 · LJC
Syva Co.
Microbiology · 113d
Cleared Mar 12, 1991
NEXT WAVE(R) PHYSIOACCOUSTIC(TM) CHAIR
K905256 · IOR
Next Wave, Inc.
Physical Medicine · 111d
Cleared Mar 12, 1991
EDLICH WOUND MANAGEMENT TRAY
K905572 · MCY
Sorex Medical
General & Plastic Surgery · 90d
Cleared Mar 12, 1991
EXACTECH HUMERAL SHOULDER PROSTHESIS
K905577 · HSD
Exactech, Inc.
Orthopedic · 90d